Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S

FDA Recall Z-0707-2022 · Posted None

Recalling FirmBrasseler USA, Medical L.L.C.
Recall StatusTerminated
Product CodeHTY
Date Initiated2022-01-28
Date Terminated2023-02-03
Product Quantity231 units

Reason for Recall

One lot of product was distributed in unsealed packaging

Firm Action

The firm initiated the recall by telephone on 01/28/2022 and followed with a letter delivered by email. The letter explained the issue and requested the consignee set the affected product aside to be returned to the recalling firm.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of OH, MI, AZ, FL, CA, TN, TX, SC, PA IL, ID.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K945670KIRSCHNER (K-WIRE), STEINMAN PINSBrasseler USA I, L.P. · 1995-03-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑